Cleared Traditional

K982902 - PERIPHERAL NERVE STIMULATION

K982902 is an FDA 510(k) clearance for PERIPHERAL NERVE STIMULATION, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982902 · Medtronic Vascular · Neurology device
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Nov 1998
Decision
88d
Days
Class 2
Risk

K982902 is an FDA 510(k) clearance for the PERIPHERAL NERVE STIMULATION. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 10, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K982902

510(k) Number K982902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1998
Decision Date November 10, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZF Device Classification - Class 2, Special Controls

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 24
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K982902.
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
K142432 · Bioness, Inc. · Feb 2015
RENEW NEUROSTIMULATION SYSTEM
K000852 · Advanced Neuromodulation Systems · Jan 2001
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105 · Medtronic Vascular · Apr 2000
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
K960631 · Medtronic Vascular · May 1996
TECOTHANE 55D
K950425 · Medtronic Vascular · Apr 1995
MEDTRONIC MODEL 3990 PNS LEAD
K925952 · Medtronic Vascular · Aug 1993